40 results
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21ms
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Sources: EU EUDAMED, US FDA
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Affiniti
FDA UDI
TORNIER, INC.·00846832024803·GLENOID REAMER
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502744·TeWa CJ-Type 3025: coated acupuncture needles ...
TEWA
FDA UDI
asia-med GmbH·04251282510060·TeWa CJ-Type 3025: coated acupuncture needles ...
Isolator Surgical Ablation System
FDA UDI
ATRICURE, INC.·00818354010756·Isolator Synergy Surgical Ablation System, Glid...
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741104190·Catheter Placement Kit
Isolator Surgical Ablation System
FDA UDI
ATRICURE, INC.·10840143902161·Isolator Synergy Surgical Ablation System, Glid...
Zavation
FDA UDI
Zavation LLC·00842166167599·4-Level, 52mm Cervical Plate
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688020004·
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 23, 2025
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·September 25, 2024
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 23, 2025
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
FDA 510(k)
FDA Class 1
·Radiology
KIPPMED I.V. MANIFOLD
FDA 510(k)
FDA Class 2
·General Hospital
First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash
FDA Recall
Terminated
·Certified Safety Mfg Inc·Product code LRR·March 20, 2018
First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 ¿Deluxe Cabinet ¿3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLB¿CSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R ¿200 Person Deluxe Cabinet - Refill R508016 Eye Wash ¿4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet ¿316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36M¿Delmarva Power/ACE¿w/Logo R508016 Eye Wash¿4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC¿4 ¿200 Person Deluxe Cabinet ¿4 Shelf R508016 Eye Wash¿4 oz. 32-000452-0000 K206140 CLX ¿100 Person ¿Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet ¿Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK ¿Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV¿7SH¿Standard Cabinet Swing Out Door¿2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash
FDA Enforcement
Class II
·Terminated·Certified Safety Mfg Inc·April 18, 2018
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Death
·ATRICURE, INC.·Product code GEI·March 3, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011